Akorn, Inc. and Cipla, Ltd., a pharmaceutical company located in Mumbai, India, have signed an exclusive development and supply agreement for an oral ANDA drug product for the prevention of organ transplant rejection.

Under the terms of the 10-year agreement, Cipla will be responsible for the development, manufacturing and supply of the drug product. Akorn will be responsible for the bioequivalency clinical trial, ANDA submission and marketing and distribution in the U.S. and PR. Cipla will receive milestone fees for the ANDA development and Akorn will own the ANDA. Akorn expects to launch the product in late 2009. Under the agreement, Akorn and Cipla will share revenues on a 60/40 basis.

Arthur S. Przybyl, Akorn’s president and chief executive officer, stated, “This exclusive drug development and supply agreement reinforces our commitment to expanding our business relationship with Cipla.” According to 2006 IMS data, the total market size for this drug is approximately $750 million for all indications.